Study of BHV-4157 in Alzheimer's Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Alzheimer Disease
In brief
Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or placebo, were administered orally once daily. Duration of treatment is 48 weeks in double-blind phase. There is also a screening period of up to 42 days; and a 4-week post-treatment observation period. Eligible participants who completed the double-blind treatment phase had the opportunity to receive open-label troriluzole for up to 48 weeks in an open-label extension (OLE) phase.
Key facts
- Study ID
- NCT03605667
- Run by
- Biohaven Pharmaceuticals, Inc.
- People needed
- 350
- Starts
- 2018-07-31
- Expected to finish
- 2021-12-23
- Last updated by the study team
- 2023-12-06
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Xenoscience, Inc. — Phoenix, Arizona, United States
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Banner Sun Health Research Institute — Sun City, Arizona, United States
- Neurology Center of North Orange County — Fullerton, California, United States
- University of California, San Diego — La Jolla, California, United States
- University of Southern California — Los Angeles, California, United States
- SC3 Research Group - Pasadena — Pasadena, California, United States
- Geriatric and Adult Psychiatry — Hamden, Connecticut, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH — Stamford, Connecticut, United States
- Brain Matters Research — Delray Beach, Florida, United States
- University of Miami — Miami, Florida, United States
- USF Health Byrd Alzheimer's Institute — Tampa, Florida, United States
- Northwestern University — Chicago, Illinois, United States
- Great Lakes Clinical Trials — Chicago, Illinois, United States
- Southern Illinois University — Springfield, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Kentucky — Lexington, Kentucky, United States
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
- Northern Light Acadia Hospital — Bangor, Maine, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- University of Michigan, Ann Arbor — Ann Arbor, Michigan, United States
- Michigan State University — East Lansing, Michigan, United States
- Galen Research — Chesterfield, Missouri, United States
Full record on ClinicalTrials.gov
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